Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 and over NCI GOG-0179 ECOG-G0179, NCT00003945, GOG-0179

Objectives

1. Compare the response rate and survival of patients with stage IVB, recurrent, or persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus topotecan vs methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). (Arm III (MVAC) closed to accrual effective 07/23/2001.)
2. Compare the toxic effects of these regimens in this patient population.
3. Compare health-related quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy
  • Eligible subtypes:
    • Squamous cell carcinoma
    • Adenosquamous carcinoma
    • Adenocarcinoma



• Measurable disease by physical examination, radiography, CT scan, or MRI
  • Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions are at least 3 cm and well defined



• No craniospinal metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 6 weeks since prior chemoradiotherapy and recovered
• No prior chemotherapy except when used concurrently with radiotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• See Chemotherapy
• At least 3 weeks since prior radiotherapy only and recovered

Surgery:

• Recovered from prior surgery

Other:

• No prior anticancer treatment that would preclude study therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Alkaline phosphatase no greater than 3 times normal

Renal:

• Creatinine no greater than 1.5 mg/dL
• No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No clinically significant infection
• No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
• Body surface area no greater than 2.0 m²

Expected Enrollment

A total of 400 patients (133 per treatment arm) will be accrued for this study within 2 years. (Arm III closed to accrual effective 07/23/2001.)

Outline

This is a randomized, multicenter study. Patients are stratified according to GOG performance status. Patients are randomized to one of three treatment arms. (Arm III closed to accrual effective 07/23/2001.)

• Arm I: Patients receive cisplatin IV once every 21 days.



• Arm II:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV (beginning after topotecan infusion) on day 1. Courses repeat every 21 days.



• Arm III:Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days 2, 15, and 22, and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days. (Arm III closed to accrual effective 07/23/2001.)

Treatment in all arms continues for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. (Arm III closed to accrual effective 07/23/2001.)

Quality of life is assessed before randomization, before course 2, before course 5 (arms I and II), before course 4 (arm III), and at 9 months. (Arm III closed to accrual effective 07/23/2001.)

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Long HJ 3rd, Monk BJ, Huang HQ, et al.: Clinical results and quality of life analysis for the MVAC combination (methotrexate, vinblastine, doxorubicin, and cisplatin) in carcinoma of the uterine cervix: A Gynecologic Oncology Group study. Gynecol Oncol 100 (3): 537-43, 2006.[PUBMED Abstract]

Long HJ 3rd, Bundy BN, Grendys EC Jr, et al.: Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol 23 (21): 4626-33, 2005.[PUBMED Abstract]

Monk BJ, Huang HQ, Cella D, et al.: Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: a Gynecologic Oncology Group Study. J Clin Oncol 23 (21): 4617-25, 2005.[PUBMED Abstract]

Grendys EC Jr, Long HJ, Bundy BN, et al.: Randomized phase III trial of cisplatin vs cisplatin plus topotecan vs the combination of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) in stage IVB, recurrent or persistent carcinoma of the uterine cervix: a Gynecologic Oncology Group study. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-039, 12, 2004.

Monk BJ, Huang H, Cella D, et al.: Quality of life outcomes from GOG 179: a phase III trial of cisplatin vs cisplatin/topotecan in recurrent or persistent carcinoma of the cervix. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-142, 42, 2004.

Plaxe SC, Brooks SE, Tian C, et al.: Influence of race on tolerance of platinum-based chemotherapy and clinical outcomes in women with advanced and recurrent cervical cancer: a pooled analysis of 3 Gynecologic Oncology Group studies. Am J Obstet Gynecol : , 2008.[PUBMED Abstract]

Moore DH, Tian C, Monk BJ, et al.: Factors predictive of response to cisplatin-based chemotherapy in stage IVB persistent or recurrent cervical carcinoma: a multivariate analysis of three Gynecologic Oncology Group trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-5534, 282s, 2007.

Tewari KS, Monk BJ: Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer. Curr Oncol Rep 7 (6): 419-34, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Harry Long, MD, Protocol chair		Ph: 507-284-4320 Email: long.harry@mayo.edu

Eastern Cooperative Oncology Group

Higinia Cardenes, MD, PhD, Protocol chair		Ph: 317-274-2524; 888-600-4822 Email: hcardene@iupui.edu

Registry Information
Official Title		A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix
Trial Start Date		1999-06-28
Trial Completion Date		2007-01-14
Registered in ClinicalTrials.gov		NCT00003945
Date Submitted to PDQ		1999-06-18
Information Last Verified		2004-09-09
NCI Grant/Contract Number		CA27469

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